Megan Brooks | April 28, 2023
Composite cognitive Z-score improved significantly at 13 and 26 weeks and remained above baseline at 52 weeks in comparison with matched ADNI controls. “These are very promising data,” Hey told conference attendees.
He noted that the safety profile of ALZ-801 remains favorable and consistent with prior safety data. Common adverse events were mild nausea and SARS-CoV-2 infection. There were no drug-related serious events or amyloid-related imaging abnormalities-edema (ARIA-E).
The phase 3 APOLLOE4 study of ALZ-801 is underway. This double-blind, randomized study is comparing oral ALZ-801 to placebo over 78 weeks for roughly 300 adults with early AD who have the APOE4/4 genotype. APOLLOE4 is expected to be completed in mid 2024.